Different Surgical Approaches for Treatment of UPJ Obstruction in Children: Prospective Randomized Clinical Trial

Surgery Clinical Trial

Official title:

Different Surgical Approaches for Treatment of UPJ Obstruction in Children: Prospective Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05748964
• Other study ID #: AKA1712
• Status: Not yet recruiting
• Start date: April 1, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: February 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study aimed to evaluate the clinical efficacy of laparoscopic pyeloplasty (LP) for ureteropelvic junction obstruction (UPJO) via retroperitoneal and transperitoneal approaches.

Description:

Ureteropelvic junction obstruction (UPJO) is the most common congenital abnormality of the kidney and is responsible for flank pain, recurrent urinary infections, hydronephrosis and the loss of renal function. Until recently, open pyeloplasty (OP) was the standard surgical treatment modality for UPJO.However, with the development of laparoscopic devices and surgical technology, laparoscopic pyeloplasty (LP) has become a more beneficial choice for the patients with UPJO than open surgery because of the advantages of excellent visualization, minimal trauma, rapid postoperative recovery, good cosmetic result, and a nearly successful rate compared with open pyeloplasty. The first LP in children was performed in 1995. It has gained popularity for older children. LP can be performed though retroperitoneal and transperitoneal approaches. Which surgical method is better is still controversial.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 1, 2025
• Est. primary completion date: April 1, 2024
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

Inclusion Criteria:

• Age above two years.

• Unilateral UPJO.

Exclusion Criteria:

• Age below two years.

• Bilateral UPJO.

• Recurrent UPJO.

• Malrotated kidneys and renal fusion anomalies.

Related Conditions & MeSH terms

• Surgery
• Urologic Diseases

Intervention

Procedure:
• Laparoscopic pyeloplasty
Twenty patients presented with ureteropelvic junction obstruction [UPJO] will be divided into two equal groups. The first was subjected to trans-peritoneal pyeloplasty while the second was subjected to retroperitoneal pyeloplasty.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative time	Operative time	From April 1, 2023 to April 1, 2024
Secondary	Convergence rate	Convergence to open pyeloplasty	From April 1, 2023 to April 1, 2024
Secondary	Post operative complications	Post operative complications	From April 1, 2023 to April 1, 2024
Secondary	Hospital stay	Hospital stay	From April 1, 2023 to April 1, 2024